Posted by Michael Wonder on 26 Oct 2019
European Commission approves Astellas’ Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation
25 October 2019 - Approval follows accelerated assessment, orphan designation by European Medicines Agency.
Astellas announced today that the European Commission has approved the oral once-daily therapy Xospata (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or refractory (resistant to treatment) acute myeloid leukaemia (AML) with a FLT3 mutation (FLT3mut+). Gilteritinib has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation—FLT3 internal tandem duplication and FLT3 tyrosine kinase domain mutation.
This approval is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML.
